The Effect of Minimal Flow Sevoflurane Anesthesia

Not Applicable

Completed

• Conditions: Anesthesia; Functional; Anesthesia Awareness
• Interventions: Drug: Sevoflurane inhalant product

• Registration Number: NCT04813952
• Lead Sponsor: Sisli Hamidiye Etfal Training and Research Hospital

Brief Summary

Our aim is to investigate the effect of minimal flow anesthesia with sevoflurane on hemodynamics and arterial blood gas parameters in laparoscopic cholecystectomy operations.

Detailed Description

Introduction: Low-flow anesthesia techniques have regained popularity in recent years with the development of low solubility volatile agents such as sevoflurane and desflurane, and modern anesthesia devices. Reducing the flow of fresh gas as much as possible will reduce the amount of volatile agent used, thus preventing air pollution, providing lower costs, and also preserving heat and moisture in the respiratory tract by using rebreathing systems. Laparoscopic surgery is superior to open surgical techniques due to its minimally invasive nature, less postoperative pain, less incidence of wound infections, shortening the hospitalization, and allowing patients to return to their normal lives sooner after the operation.

Our aim is to investigate the effect of minimal flow anesthesia with sevoflurane on hemodynamics and arterial blood gas parameters in laparoscopic cholecystectomy operations.

Material and Method: Seventy patients with ASA (American Society of Anesthesiologists) class I-II between the ages of 18-65 undergoing elective laparoscopic cholecystectomy were included in the study. After the patients were randomly selected by computer, they were divided into two equal groups as Group M (minimal flow anesthesia group) with fresh gas flow 0,5 L.min-1 and Group C (high flow anesthesia/ control group) with fresh gas flow 4 L.min-1. In both groups. Demographic data, duration of anesthesia, operation times, recovery times, hemodynamic parameters and arterial blood gas parameters of all patients were recorded. The patient data collected in both groups were compared statistically.

Study Timeline

• Study Start: 2021-02-15
• Study First Submitted: 2021-03-10
• Study First Submitted QC: 2021-03-21
• Study First Posted: 2021-03-24
• Primary Completion: 2021-04-30
• Study Completion: 2021-05-10
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-17
• Last Update Posted: 2021-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• ASA (American Society of Anesthesiologists) class I-II
• The operation time between 60-180 minutes

Exclusion Criteria

• Severe cardiac disease
• COPD (Chronic Obstructive Pulmonary Disease)
• Severe liver and kidney disease,
• Diabetes mellitus
• Morbid obesity
• Alcohol and/or drug addiction
• Risk or history of malignant hyperthermia
• Pregnancy and lactation
• Emergency cases
• Operation time less than 60 minutes and longer than 180 minutes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group M	Sevoflurane inhalant product	Group M is minimal flow anesthesia group with fresh gas flow 0,5 L.min-1. Thirty five patients with ASA class I-II and between the ages of 18-65 undergoing elective laparoscopic cholecystectomy will be included. These patients were planned to be administered sevoflurane anesthesia with 0,5 L.min-1 flow under general anesthesia.
Group H	Sevoflurane inhalant product	Group H is high flow anesthesia group with fresh gas flow 4 L.min-1. Thirty five patients with ASA class I-II and between the ages of 18-65 undergoing elective laparoscopic cholecystectomy will be included. These patients were planned to be administered sevoflurane anesthesia with 4 L.min-1 flow under general anesthesia.

Primary Outcome Measures

Name	Time	Method
CHANGE IN PaCO2	from the beginning to the end of anesthesia	The partial pressure of carbon dioxide is the measure of carbon dioxide within arterial blood.
CHANGE IN P/F	from the beginning to the end of anesthesia	PaO2/FiO2 ratio is the ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2 expressed as a fraction, not a percentage). P/F ratio is a widely used clinical indicator of hypoxaemia

Secondary Outcome Measures

Name	Time	Method
volatile agent consumption amount	from the beginning to the end of anesthesia	the total amount of volatile agent (sevoflurane) consumed at the end of the surgery

Trial Locations

Locations (1)

Nebia Peker; 🇹🇷 Şi̇şli̇, Istanbul, Turkey